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U.S. Department of Health and Human Services

Devices@FDA

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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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83 supplements returned for P120005

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Device Name Company Date Approved Supplement Reason Other Information
dexcom g4 platinum continuous glucose monitoring system

supplement #: S032
Dexcom, Inc. Jan 22, 2015 process change - manufacturer/sterilizer/packager/supplier  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S033
Dexcom, Inc. Aug 19, 2015 change design/components/specifications/material  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S034
Dexcom, Inc. Apr 16, 2015 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S035
Dexcom, Inc. Jun 03, 2015 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4tm platinum continuous glucose monitoring system

supplement #: S036
Dexcom, Inc. Jul 02, 2015 change design/components/specifications/material  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S037
Dexcom, Inc. Sep 23, 2015 change design/components/specifications/material  
dexcom g4 platinum continuous glucose monitoring system

supplement #: S038
Dexcom, Inc. Nov 06, 2015 process change - manufacturer/sterilizer/packager/supplier  
dexcom g4tm platinum continuous glucose monitoring system; dexcon g5 mobile continuous glucose monitoring system

supplement #: S039
Dexcom, Inc. Oct 23, 2015 process change - manufacturer/sterilizer/packager/supplier  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S040
Dexcom, Inc. Nov 25, 2015 process change - manufacturer/sterilizer/packager/supplier  
dexcom g5 mobile continuous glucose monitoring system

supplement #: S041
Dexcom, Inc. Dec 20, 2016 change design/components/specifications/material Approval Order
Summary of Safety & Effectiveness
Labeling
  We welcome your comments and feedback about Devices@FDA.
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